Solid forms of a thienopyrimidinedione ACC inhibitor and methods for production thereof

Abstract

The present invention provides solid forms of compounds useful as inhibitors of Acetyl CoA Carboxylase (ACC), compositions thereof, methods of producing the same, and methods of using the same in the treatment of ACC-mediated diseases.

We claim: 
     
       1. A crystalline form of Compound 1: 
       
         
           
           
               
               
           
         
         (Compound 1 Form I) characterized by an X-ray powder diffractogram comprising the following peaks: 9.3, 15.0, and 19.8°2θ±0.2°2θ, as determined on a diffractometer using Cu—Kα radiation at a wavelength of 1.54 Å. 
       
     
     
       2. The crystalline form of  claim 1 , wherein the diffractogram comprises one or more additional peaks at 16.0, 24.0, 25.8, and 27.3°2θ±0.2°2θ. 
     
     
       3. The crystalline form of  claim 2 , wherein the diffractogram comprises peaks at 16.0 and 25.8°2θ±0.2°2θ. 
     
     
       4. The crystalline form of  claim 1 , characterized by a differential scanning calorimetry (DSC) curve that comprises an endotherm between 189° C. to 193° C. 
     
     
       5. A pharmaceutical composition comprising the crystalline form of  claim 3  and a pharmaceutically acceptable carrier, adjuvant or diluent. 
     
     
       6. A pharmaceutical composition comprising a therapeutically effective amount of the crystalline form of Compound 1 according to  claim 1 , and a pharmaceutically acceptable carrier, adjuvant or diluent. 
     
     
       7. A method of inhibiting ACC in a patient in need thereof comprising administering to the patient the crystalline form of  claim 1 . 
     
     
       8. The method according to  claim 7 , wherein the patient is suffering from non-alcoholic fatty liver disease. 
     
     
       9. The method according to  claim 8 , wherein the non-alcoholic fatty liver disease is non-alcoholic steatohepatitis. 
     
     
       10. The method of  claim 7 , wherein the patient is suffering from acne vulgaris.